Non-Narcotic Pain Control After ACL Reconstruction

Phase 3

Recruiting

• Conditions: ACL - Anterior Cruciate Ligament Rupture; ACL Injuries
• Interventions: Drug: Ketorolac; Drug: dispense of study drug

• Registration Number: NCT06973785
• Lead Sponsor: The Cleveland Clinic

Brief Summary

This is a double-blind randomized controlled trial of standard of care therapy, either oral ketorolac (experimental group) or oral oxycodone (control group) to demonstrate efficacy in reducing the percentage of narcotic doses taken and documenting the number of patients with no exposure to any narcotics (take zero oxycodone) after undergoing primary knee ACL reconstruction outpatient surgery.

Detailed Description

This is a multi-center, 2 arm, randomized 1:1 controlled trial, with a blinded patient and outcome assessment study. Narcotics are currently the standard of care as part multimodal pain control in major joint surgery including ACLR. Twelve (12) ketorolac (10mg) and twelve (12) oxycodone (5mg) tablets will be shrouded in identical capsules designed for blinding. The capsules will be dispensed in sealed single-pill release blister packets. The enrolled patients will be randomized by the surgeon. The surgeon, clinical team, and patient will be blinded as to treatment (double-blind study). The rescue medication will be specific to each treatment group, encapsulated for blinding, and in a packet labeled RESCUE medication. For the experimental group (ketorolac) they will have 12 oxycodone as rescue medication. For the control group (oxycodone) they will have 12 diclofenac as rescue medication. Both groups will also be given acetaminophen for the first 72 hours. All medications in our multimodal approach will be provided postoperatively after ACL reconstruction to both groups. The primary endpoint will be the percentage reduction in narcotics pills per patient in each group in first 72 hours postoperatively verified from sealed packages.

Study Timeline

• Study First Submitted: 2025-03-07
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-07
• Last Update Submitted: 2025-05-07
• Study Start: 2025-05-15
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 15-55 years
• Primary Autograft ACL surgery
• Ability to take oral medication and willingness to patriciate in a virtual 1 and 2 week follow-up pill counts

Exclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for t the duration of the study
• Male or female, aged 15-55 years
• Primary Autograft ACL surgery
• Ability to take oral medication and willingness to patriciate in a virtual 1 and 2 week follow-up pill counts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone- Narcotic	Ketorolac	Arm 1
Ketorolac	dispense of study drug	Arm 2

Primary Outcome Measures

Name	Time	Method
Primary outcome	30 days	How many narcotic pills were consumed

Trial Locations

Locations (3)

Cleveland Clinic Coral Springs; 🇺🇸 Coral Springs, Florida, United States

Cleveland clinic sports medicine; 🇺🇸 Garfield, Ohio, United States

Cleveland Clinic; 🇺🇸 Strongsville, Ohio, United States